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New Medical Devices and Health Care SAMUEL 0. THIER The purpose of this book is to describe how somebody comes up with an idea for a medical device, develops it, and tests it; how it is regulated and marketed; how it is introduced; and then how it serves the purposes of health care. Although it is easy to believe that the device is the primary concern, it is my intent to caution against that perspective. Medical devices, no matter how innovative, are means to an end. The end, of course, is prevention of disease, correction of disease, and rehabilitation from disease. Those who are involved in the development of medical devices and want to have them used properly must be extremely frustrated by the fact that devices often are blamed for the rising cost of health care. Yet, it is impossible to imagine anybody practicing medicine today without medical devices and medical technology. Why is it that we have a dependence on technology for skilled practice and at the same time a resistance to technology? I think there are several types of reasonscultural, economic, and scientific. I will quickly scan the first two and then focus a bit more on the scientific base of medical devices. The problem in introducing new technology is an old one. For example, a newspaper editorial in 1834 said of a medical instrument: "That it will ever come into general use, notwithstanding its value, is extremely doubtful because its beneficial application requires much time and gives a good bit of trouble, both to the patient and the practitioner because its hue and character are foreign and opposed to all our habits and associations. There is something even ludicrous in 3

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4 MEDICAL DEVICE INNOVATION AND HEALTH CARE the picture of a gray physician proudly listening through a long tube applied to the patient's thorax" (McKusick, 1958). That London Times editorial was criticizing the introduction of the stethoscope. New medical technologies since then have also been resisted, sometimes by the public, sometimes by the profession, sometimes by both. In general, the medical profession is a very conservative group and does not accept new technologies readily. That is not all bad. Readers of the New England Journal of Medicine and the Journal of the American Medical Association (JA MA) every week see reports about the introduction of some new technology, some new test, something that will advance the way in which we practice medicine. If we were to change according to each of those reports, we would end up changing directions like Ping-Pong balls, and our use of technology would be ludicrous. One of the tensions in the system is between the natural resistance to new technology and the fascinated attraction to it. That emotional ambivalence is an important reality. But there is a more important economic resistance: technology generally and devices particularly have become identified as culprits in the rise of health care costs. The general sense is that every time a new technology is introduced, the costs of care are driven up. That may be true if the technology is expensive and is used often. However, technology also can lower costs in many health care circumstances. Sometimes the cost-cutting effect is direct and obvious. Other times it is indirect, measurable mainly in the quicker return of patients to a productive existence, which rarely is calculated in the costs of introducing medical technology. Some of the stigma on technology as costly stems from its improper siting. Because of the health care reimbursement system, we have commonly put technology in the most expensive settings, where the support staff and overhead costs are the highest. Other blame attaches to our failure to ensure skilled use of the technology. The assumption that we could release technology on an unprepared medical profession and have it spread with appropriate skills throughout the nation is a delusion. That simply does not happen, and thus we have persons applying technologies who are prepared neither by skill nor by knowledge of the proper indications for use. A further problem relates to a system that pays practitioners more for technologic skills than for cognitive medical skills. When that happens, it drives the use of technology into inappropriate applications. Something I wrote a few years ago puts it in perspective from the physician's standpoint.

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NEW MEDICAL DEVICES AND HEALTH CARE s It is a paradox of modern medicine that, as technology provides for greater precision in diagnosis and treatment, practicing physicians are becoming less critical and efficient in its use. The difficulties for the physician in practice are understandable. The last two to three decades have been historically unique in the rate at which new biomedical knowledge has been produced and applied. New insights into the basic mechanism of disease have been translated into new diagnostic tests and therapeutic modalities.... New technology is frequently introduced through journal articles, consultants' suggestions, con- ferences, postgraduate courses, and newsletters. Often there is inadequate perspective provided for the use of the technology and certainly inadequate perspective in a clinical circumstance or in relation to other existing technol- ogies. The physician, understandably, continues to use what has proven helpful in the past and merely adds new technology to established patterns. The result is a proliferation of technology rather than substitution of newer and better approaches for outdated ones (Tinier, 1983~. What are we to do in response to burgeoning innovation? It does not permit time for assimilation of the information that would enable us to make proper use of the technology and ensure that patients will benefit to the maximum extent possible from innovation. The way in which we deal with technology does not permit focused analysis of how good it is and how well it works, nor does it permit effective long-range monitoring of who uses it and how well they use it. In the assessment of medical technology there are several perspec- tives that must be satisfied. The needs of somebody who is pondering reimbursement for a technology differ considerably from the needs of a hospital deciding whether it wishes to introduce the technology for the care of its patients That information, in turn, differs from what physicians need to know to change their practice patterns and use the technology, and that differs from what a patient needs to know to ask proper questions of the doctor. I would like to suggest a framework for introducing technology that will enable us to determine where that technology fits in the scheme of things and what its contribution to health care might be. The perspective is that of the health profession, the people conducting screening for, and prevention of, disease and employing diagnostic technology, therapeutic technology, and rehabilitative technology. The development of health care in the past century first emphasized diagnosis, because it was something a physician could actually do. Much later came the methods of effective therapy that currently get so much attention. The discovery of, and investment in, good screening techniques and in major rehabilitative measures is recent, but it is probably much more important economically than the diagnostic and

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6 MEDICAL DEVICE INNOVATION AND HEALTH CARE: therapeutic modalities. The result of this developmental history is that the reimbursement system has been focused on diagnosis and therapy instead of screening and rehabilitation. SCREENING Screening has both positive and negative aspects. A good example of a positive screening technology is the test for AIDS virus antibody. The test had two major goals initially. One was to protect the blood supply and the other was to provide epidemiologic information. Its theoretical strength in protecting the blood supply was quickly proven. Because the procedure was readily developed, inexpensive, broadly applicable, accurate, and became more accurate in practice, it repre- sented a superb screening test. However, when screening tests go beyond something as focused as protecting the blood supply to screening populations for AIDS a fatal, incurable disease with social stigmas~uestions of individual rights versus protection of the public are raised. False-positive results that have little effect on protection of the blood supply become a major concern in screening populations with a low incidence of the disease. The AIDS virus antibody test protected a resource, provided excellent epidemiologic information, was inexpensive, and will have an enormous payback, because it will be done over and over again for years to come in ever-larger segments of the population. That makes it a very successful technology. For an example of a potentially negative side of screening, there is mammography a superb test. It enables us to identify a lesion in a woman's breast at a very early stage. A pioneering controlled clinical trial demonstrated that, in women over age 50, mammography could reveal lesions sufficiently early for successful therapeutic intervention. In those women, mammographic screening was cost-effective. As the technology improved, the dose of radiation was lowered, the pictures were of better quality, and several logical assumptions were made. One was that if the procedure could be performed at a lower dose and if it was more accurate, it could be applied to a larger population of women, which would increase the benefits. Therefore, the screening was applied in a demonstration project to women less than 50 years old. But the test is not without risk, particularly in younger women. Also, we are still debating the effects of radiation at low dose. Thus, we now had a risk without a documented benefit. The entire issue became exceedingly heated. The debate cast doubt on the very effective screening for women over age 50, confused women completely as to whether mammography was good or bad, drove them away from

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NEW MEDICAL DEVICES AND HEALTH CARE diagnostic mammography for which there was no question of benefit, and created havoc. The reason for that havoc was an overzealous application of a screening technology to a group of women for whom there was no scientific proof that the technology was beneficial. DIAGNOSIS Technologic advances in medical diagnosis have boomed in only a couple of decades. But they did not always find ready acceptance. Computed tomographic (CT) scanning was resisted vigorously. It was resisted for the same reasons, almost, that the stethoscope was resisted by the London Times. There was an irrational concern about whether this expensive piece of equipment really should be let loose. Now, of course, CT scanning has replaced less accurate procedures that are more costly and dangerous. It has been improved in use and it has become an adjunct to other diagnostic technologies and therapeutic technologies. It has done almost anything you could ask of a technology and has reduced cost and suffering to an enormous degree. Reduction in suffering is very hard to calculate in economic terms but is real to patients nonetheless. We are about to replay the CT story on a newer imaging technology. The subject this time is magnetic resonance imaging (MRI). This is a technology of high initial expense that is able to give tremendously accurate information about selected areas of the human anatomy and selected disorders. It needs a period of time during which people can learn to use it and learn and apply the possibilities it affords. Then we can begin to ask the rigorous questions required before the wider diffusion of MRI. That is the positive side on diagnosis. What is the negative side? Endoscopy offers perhaps the best example. Fiber-optic endoscopy came forward with great promise. The assumption was that without using radiation one could look inside a patient and see, for example, upper gastrointestinal bleeding, discern the site of the bleeding, treat the patient more specifically, and improve the survival rate. Everything happened except the last. The survival rate for upper intestinal bleeding is exactly what it has been for the past 25 years. And yet there is an increasing use of endoscopy in patients with gastrointestinal bleeding, even though the scientific foundation for its effect on outcome is weak. The continued application of a test on the basis of an unsubstantiated rationale does not help the introduction and diffusion of technology. My general observation is that when we have introduced better methods of diagnosis to improve patient outcome the improvement has rarely occurred. Better diagnosis probably has helped to discern

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8 MEDICAL DEVICE INNOVATION AND HEALTH CARE: the natural history of disease, but better outcomes have generally resulted from better insights into the mechanism of disease. That is not to say that more accurate diagnosis should be eschewed. It is to say that the real reason for better methods of diagnosis seldom is that treatment will suddenly be more effective. THERAPY Turning to the subject of therapy, we also have subsets. We can classify it into Lewis Thomas's "supportive therapy," "halfway technology," and really effective "high technology." Supportive means that there is no therapy to be offered. It is illustrated in the old Luke Fildes painting of the doctor sitting at a child's bedside, worrying terribly about the patient but having no therapeutic skills. Under those circumstances, supportive care was all that could be offered. I am not suggesting that comforting a patient is unimportant. It is obviously very important; it simply is not as effective as proven medical or surgical therapy most of the time and also it is an exceedingly expensive use of resources for very little return. So, we move to the next step, as described by Lewis Thomas. At the next level up [after supportive therapy] is a kind of technology best termed "halfway technology." This represents the kinds of things that must be done after the fact, in efforts to compensate for the incapacitating effects of certain diseases whose course one is unable to do very much about. It is a technology designed to make up for disease or to postpone death. The outstanding examples in recent years are transplantations of hearts, kidneys, livers, and other organs, and the equally spectacular inventions of artificial organs. In the public mind, this kind of technology has come to seem like the equivalent of the high technologies of the physical sciences. The media tend to present each new procedure as though it represented a breakthrough and a therapeutic triumph, instead of the makeshift that it really is. In fact, this level of technology is, by its nature, at the same time highly sophisticated and profoundly primitive. It is the kind of thing that one must continue to do until there is genuine understanding of the mechanisms involved . . In disease.... It is a characteristic of this kind of technology that it costs an enormous amount of money and requires a continuing expansion of hospital facilities. There is no end to the need for new, highly trained people to run the enterprise. And there is really no way out of this at the present state of knowledge.... The only thing that can move medicine away from this level of technology is new information, and the only imaginable source of this information is research (Thomas, 1974~. Thomas goes on to discuss the ideal technology, which includes a

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NEW MEDICAL DEVICES AND HEALTH CARE 9 vaccine for preventing a disease, the replacement of an enzyme, the administration of a hormone to replace a deficiency state. These almost invariably inexpensive technological interventions turn out in the long run to be far more successful in maintaining or returning health. Dr. Thomas makes the argument that investment in halfway tech- nology is not worthwhile, and that the investment ought to be put into basic investigation. However, I see some problems with that approach. Take the instance of end-stage renal disease. Dialysis is available, and there is no question about what will happen to a person with renal failure if dialysis or transplantation is not provided. The person will die. The treatment is efficacious and the patient lives. The level of living ranges from those who can work to those who are incapacitated. The issue is not whether death from renal failure can be prevented. The issue is whether to expend the resources necessary to do that, and whether to encompass as broad a group of individuals as we are now treating. The lithotriptor is an example of cost in the other direction. The lithotriptor is a machine that sends shock waves, focused from outside the body, into the body to converge at a kidney stone and gradually to hammer that stone into little pieces so that it can be passed. Thus, renal calculus removal has gone from a surgical incision with a six- week to two-month recovery period to a noninvasive procedure in which we can break up the stone 60 to 80 percent of the time in one day, and have the patient back at work in less than a week. Yet, we are seeing the same sort of resistance to the lithotriptor that we have seen to every other major piece of technology. The machine does pose important questions. They have to do with whether we wish to allow a lithotriptor in every physician's office or whether we can regionalize it, given the relatively nonemergency circumstances for which it is used. Those issues concern policy, but to slow the lithotriptor's availability to individuals because we cannot deal with policy deprives people of the safest and most effective therapy almost. The best therapy is preventive. There is a broad group of patients with cystine, uric acid, and calcium stone diseases for whom medical therapy will reduce or prevent stone formations. This is where the conflict comes in. How much should be invested to provide individuals with a safety net (in the form of a lithotriptor) when that safety net also provides them with a reason not to follow their own programs in preventing illness? That conflict becomes a major concern in therapy and most obvious in the area of coronary artery disease, where the discussions have become convoluted. In coronary artery disease, all of the approaches to its diagnosis and

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10 MEDICAL DEVICE INNOVATION kD HEALTH CAM treatment could be reduced in their use if we practiced better preventive medicine. The content of prevention is gradually taking shape: the control of hypertension, the control of body weight, and the improve- ment of dietary habits. But if we took these preventive measures, the question would arise: Do we really need to become progressively more sophisticated in managing what will possibly be a smaller and smaller number of coronary disease patients? I do not have the answer, but that kind of question is emerging also as surgery is gradually being replaced in some patients by balloon angioplasty. Instead of opening the patient's chest, a balloon can be inserted through a peripheral artery and inflated to open the coronary vessels in 5 or 10 percent of coronary artery disease patients, and that rate of application will improve as the technique and technology get better. One view is that angioplasty improvements will reduce costs dra- matically for the procedure. The counteropinion is that lower cost per procedure will make it available to many more people and raise overall costs. If that latter argument holds, fallacious as it is, we might as well go out of business. Perhaps one of the better examples of the conflict in technologic therapy is in the use of cardiac pacemakers. They are tremendously beneficial to patients, and yet they have been overused because the doctors do not always understand the indications and circumstances under which they should be used. They are, nonetheless, very effective. One patient who had a pacemaker put in looked up from his bed at a cardiac monitor and saw the pacer pacing and his heart following. He felt "a new, unwarranted but irrepressible kind of vanity." I had come into the presence of a technological marvel, namely me. To be sure, the pacemaker is a wonderful miniature piece of high technology, my friend the surgeon a skilled worker in high technology, but the greatest of wonders is my own pump, my myocardium, capable of accepting electronic instructions from that small black box and doing exactly what it is told. I am exceedingly pleased with my machine-tooled, obedient, responsive self. I would never have thought I had it in me, but now that I have it in me, ticking along soundlessly, flawlessly, I am subject to waves of pure vanity.... I suppose I should be feeling guilty about this. In a way I do, for I have written and lectured in the past about medicine's excessive dependence on technology in general, and the resultant escalation in the cost of health care. I have been critical of what I have called "halfway technologies," designed to shore things up and keep flawed organs functioning beyond their appointed time. And here I am, enjoying precisely this sort of technology, eating my words (Thomas, 1984~. That was also written by Lewis Thomas. The perspective of the

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NEW MEDICAL DEVICES AND HEALTH CARE 11 patient, who benefits from the technology, versus the policymaker, who is trying to decide how it should be used, must be kept in mind. REHABILITATION I will address technologic advances in rehabilitation only briefly. We are approaching a time when neural transplantation may be possible or when the regeneration of nerves will be facilitated. These advances will be coupled with computer-assisted limbs. The opportunity to return people from a dependent status to a functional status is upon us, and I think we are going to have to take advantage of it. But again, the reimbursement structure does not yet recognize such technologic applications, and the same arguments will occur in dealing with highly expensive systems in the rehabilitative sector as are now occurring in pacemaker and cardiac surgical technology. What should we as physicians do? My sense is that we should develop a framework for technological innovation with well-defined priorities, ranking prevention and screening higher than therapeutic interventions. That set of priorities could be developed in the framework that I have presented or almost any other, but physicians certainly should play a key role in the process. Safety and efficacy are important, but utility in the clinical setting must also be considered. The way we use most medical devices in practice depends on postintroduction modifications of the devices. We work together the physicians and the manufacturers and the engineers in such modifi- cations, and suggestions gradually get built into the device. Assessment of what we have accomplished becomes very important. A broadly receptive system of information, which can be transferred to physicians and to patients, now is critical in the application of new technologies. The random input from consultant or journal or news- paper is no way to learn how new technology works. It is time to pay much more attention to the monitoring of new technology after it has been introduced. Such monitoring is easy to do in hospitals; it will be relatively easy in managed care systems. It may be difficult in the individual physician's office and abuses may occur there, but we have no excuse for not taking on all areas in which the system can be monitored and examined. If these actions are seen not in terms of protecting the ability to develop a new device, nor in terms of protecting physicians and innovators from liability, but as selecting and evolving the most appropriate use for new technology in support of health, then I think

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12 we have a process that will bring together medicine, engineering, and industry in a very exciting enterprise. MEDICAL DEVICE INNOVATION AND HEALTH CARE: REFERENCES McKusick, V. A. 1958. Cardiovascular Sound in Health and Disease. Baltimore: Williams & Wilkins. Thier, S. O. 1983. Pp. xiii-xiv in Laboratory Medicine in Clinical Practice, Harvey N. Mandell, ed. Boston: John Wright PSG, Inc. Thomas, L. 1974. The technology of medicine. Pp. 31-36 in The Lives of a Cell: Notes of a Biology Watcher. New York: Viking. Thomas, L. 1984. My magical metronome. Pp. 45~8 in Late Night Thoughts on Listening to Mahler's Ninth Symphony. New York: Bantam Books.